BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 ¿ 480T

    MDR report key: 14713456 · Received June 16, 2022

    Report

    Report Number
    2243471-2022-00561
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    March 29, 2022
    Report Date
    June 16, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA200009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA FROM THE COBAS RUNS WERE PROVIDED, HOWEVER, THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC SAMPLE ID NOR DID CLARIFY THE DISCREPANCY BEING ALLEGED (FALSE POSITIVE, FALSE NEGATIVE, OR SPECIFIC TARGET(S) DISCREPANCY AND RESULTING IN THE SAME OVERALL CALL OUT). THE PROVIDED DATA WAS REVIEWED BUT DID NOT IDENTIFY ANY ISSUE. AS ESSENTIAL INFORMATION WAS MISSING AND GIVEN THAT THE DATA REVIEW DID NOT IDENTIFY ANY ISSUE, A ROOT CAUSE INVESTIGATION WAS NOT POSSIBLE. A BATCH MDR WILL BE FILED TO REPRESENT ONE EVENT WITH A SINGLE DEVICE AS NO SAMPLE IDS OR SPECIFIC TOTAL NUMBER OF SAMPLES ALLEGED WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 6800 SYSTEM (PRODUCT CATALOG NUMBER 05524245001; UDI: (B)(4); PMA 510K: BK140196; PRODUCT CODE: MZA). THE TEST USED ON THE COBAS SARS-COV-2 FOR USE ON THE COBAS 6800-8800 SYSTEM (EUA(B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST (480T) IS 09343733190 AND THE UDI IS (B)(4).

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. A CUSTOMER FROM THE UNITED STATES ALLEGED DISCREPANT RESULTS WHEN TESTING WITH THE COBAS® SARS-COV-2 QUALITATIVE ASSAY FOR USE ON THE COBAS® 6800/8800 SYSTEMS. THE TOTAL NUMBER OF SAMPLES IS UNKNOWN. AS PER THE CUSTOMER, DISCREPANT RESULTS WERE GENERATED WHEN SAMPLES WERE TESTED ON THE COBAS 6800 AND COMPARED WITH NEWLY COLLECTED SAMPLES TESTED ON A DIFFERENT PLATFORM (ABBOT ID NOW). HOWEVER, THE ALLEGED RESULTS HAVE NOT BEEN PROVIDED. THE RESULTS WERE REPORTED OUT. NO HARM IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312892 COBAS® SARS-COV-2 ¿ 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H36371

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown